NDC 69150-139

NAPROXEN

Naproxen

NAPROXEN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Biomes Pharmaceuticals. The primary component is Naproxen.

Product ID69150-139_b91b8834-9d71-4a53-ac54-762da3d5c578
NDC69150-139
Product TypeHuman Prescription Drug
Proprietary NameNAPROXEN
Generic NameNaproxen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-03-23
Marketing CategoryANDA / ANDA
Application NumberANDA091416
Labeler NameBiomes Pharmaceuticals
Substance NameNAPROXEN
Active Ingredient Strength375 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 69150-139-15

500 TABLET in 1 BOTTLE (69150-139-15)
Marketing Start Date2015-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69150-139-15 [69150013915]

NAPROXEN TABLET
Marketing CategoryANDA
Application NumberANDA091416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-23
Inactivation Date2020-01-31

NDC 69150-139-16 [69150013916]

NAPROXEN TABLET
Marketing CategoryANDA
Application NumberANDA091416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-23
Inactivation Date2020-01-31

NDC 69150-139-14 [69150013914]

NAPROXEN TABLET
Marketing CategoryANDA
Application NumberANDA091416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-23
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN375 mg/1

OpenFDA Data

SPL SET ID:80217f60-9b41-911a-2bee-aa7de615c9d1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198013
  • 198012
  • 198014
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]